7:30 AM- Registration and Continental Breakfast

      8:30 AM-4:30 PM- Inclusive Pre-Conference Full Day Seminars 
        8:30 AM-   Seminar Begins
        10:00 AM- Refreshment Break and Exhibit Viewing
        12:00 PM- Lunch
        2:30 PM-   Refreshment Break and Exhibit Viewing
        4:30 PM-   Seminar Ends
 
        Seminar A
        A GMP Roadmap for Aseptic Processing   
        Karen S. Ginsbury, B. Pharm. M. Sc. MRPharmS., President, PCI Pharmaceutical
        Consulting Israel Ltd.
 slides
 3 slides to a page with notes
 Bonus

        I.    Aseptic Processing- Regulations, Revised Regulations, and Guidance

        II.  Aseptic Product and Process Lifecycle

        III. ICH Q10- Developing a Robust Quality System for Aseptic Processing 

        IV. Interactive Exercise- Developing a CAPA System for Aseptic Processing
              Participants will work in small groups to develop a reporting and assessment 
           system for monitoring the quality metrics of an aseptic operation.  

      V.   Toolkit: Participants will receive: A risk assessment template for HACCP to determine
            environmental monitoring locations. 

      Seminar B
        Environmental Monitoring Program Design AND Microbial Contamination Control 
        Dilip Ashtekar, Ph.D., Director, Corporate Quality Assurance, Corporate Quality, Amgen
        Felicia Ford-Rice, Senior Director, Quality Assurance, Astellas Pharma US, Inc
        Elaine Sartain, Director Customer Solutions, Pharmaceutical and Research 
      Consumables, Life Sciences Division, STERIS Corporation 
        
        Morning Workshop   slides   

                                             3 slides to a page with notes
        Efficient Environmental Monitoring Program Design for Aseptic Processing 
       
        I.    Requirements for Environmental Monitoring for Sterile Products 
 
        II.  Design an Environmental Monitoring Program and Select Sites for 
              Sterile Products 

        III. Maintain an Effective Environmental Monitoring Program 

        IV. Environmental Monitoring Data Collection, Evaluation, and Reporting    

        V.   Toolkit: A SOP Collection and Evaluation of Environmental Data

        Afternoon Workshop  slides
                                               3 slides to a page with notes 
        Microbial Control Challenges in Regulated Manufacturing Facilities and Equipment:
        Development of an Effective Microbial Control Program

        I.   Regulatory Expectations and Industry Drivers 

        II.  Disinfectant Selection Guidelines 

        III. Application Issues

        IV. Designing a Compliant Disinfectant Validation Protocol

        V.  Interactive Exercises: Case Study relative to establishment of microbial limits on 
           non-sterile equipment and Case Study relative to disinfectant validation failures